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Inmazeb Brought Regeneron A Priority Review Voucher, But Not The Type It Wanted

 
• By Sue Sutter

Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.

Tropical forest
Regeneron would have preferred a voucher awarded under the tropical disease program. • Source: Shutterstock

An Ebola drug sponsor’s request for a priority review voucher highlights a lack of regularity clarity as to the types of applications for which some vouchers can be redeemed.

In seeking approval of the Ebola treatment Inmazeb (atoltivimab/maftivimab/odesivimab-ebgn), Regeneron Pharmaceuticals, Inc. made clear its preference for a priority review voucher awarded under the tropical disease program, rather than the medical countermeasures program

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